<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201209127352N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-09-30</date_registration>
      <primary_sponsor>center for community based participatory research, Tehran university of medical sciences</primary_sponsor>
      <public_title>modification of obesity-related eating behaviors</public_title>
      <acronym></acronym>
      <scientific_title>Effect of training based on family centered empowerment model on modifying some of obesity-related eating behaviors among women in Urmia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7801</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obesity.</hc_freetext>
      <i_freetext>Intervention 1: Education based on family centered empowerment model steps will be implemented as following: Step one: The first step in family centered empowerment model is, increasing the perceived threat (perceived severity and perceived susceptibility) in the test group. Here perceived severity means to understand the risk as the absence of proper eating behavior and perceived susceptibility means to understand how a person is at risk for the diseases resulting from lack of proper eating behavior. Thus, by holding three group discussions and question and answer of participants about right and wrong eating behavior and unhealthy eating behaviors that will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). The second step in the empowerment model of family-centered, is problem solving: Problem solving will be conducted via group discussions in a manner that promotes self-esteem and self-control in the test group. The goal of this step is, understanding the problem by women and providing its solution. Hence problem-solving sessions, will hold in three 45-minute group discussions in small group of women, with together, under supervision of the researcher, with an objective example of their situation and expressing their experiences and also will discuss in what they have done so far in order to modify their wrong food behavior and so at this stage, women get practically familiar with their problems and their solving process. and this issue will enhance their efficacy. The third step in the family-centered empowerment model, is participation in training: in this step, discussed topics in previous meetings, on educational participation, transferred by the pamphlets and booklet to the active member of the family, to their husbands in this research, by women, in order to participate and support of their wives to modify the improper eating behavior. The fourth step in family centered empowerment model is evaluation that includes two stages: process evaluation and final evaluation. Intervention 2: no intervention in the control group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Mataji Amirroud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no.23, 1st alley, 1st ave, 9 ave, Ammar st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 44 1345 5169</telephone>
        <email>m.mataji2009@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences - Department of Health (Campus Alvand)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Hossein Taghdisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Faculty of Medical Sciences, St.Alvand,  Argentina's Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 218777674</telephone>
        <email>taghdisi.mh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 18 and 60 years old; married; having BMI above 25; not pregnant at the time of project; can read and write; ability to participate in the empowerment program; willingness to participate in project&#13;
Exclusion criteria: Unwillingness or impossibility to continue to participate in the study; unwillingness to complete research tools; not participate in problem-solving sessions and in the training program.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Education based on family centered empowerment model steps will be implemented as following: Step one: The first step in family centered empowerment model is, increasing the perceived threat (perceived severity and perceived susceptibility) in the test group. Here perceived severity means to understand the risk as the absence of proper eating behavior and perceived susceptibility means to understand how a person is at risk for the diseases resulting from lack of proper eating behavior. Thus, by holding three group discussions and question and answer of participants about right and wrong eating behavior and unhealthy eating behaviors that will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). The second step in the empowerment model of family-centered, is problem solving: Problem solving will be conducted via group discussions in a manner that promotes self-esteem and self-control in the test group. The goal of this step is, understanding the problem by women and providing its solution. Hence problem-solving sessions, will hold in three 45-minute group discussions in small group of women, with together, under supervision of the researcher, with an objective example of their situation and expressing their experiences and also will discuss in what they have done so far in order to modify their wrong food behavior and so at this stage, women get practically familiar with their problems and their solving process. and this issue will enhance their efficacy. The third step in the family-centered empowerment model, is participation in training: in this step, discussed topics in previous meetings, on educational participation, transferred by the pamphlets and booklet to the active member of the family, to their husbands in this research, by women, in order to participate and support of their wives to modify the improper eating behavior. The fourth step in family centered empowerment model is evaluation that includes two stages: process evaluation and final evaluation</i_keyword>
      <i_keyword>no intervention in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Food behavior. Timepoint: Before the intervention, two months after the intervention. Method of measurement: food behaviors checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Food behavior self efficacy. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Food behavior self efficacy questionnaire.</sec_outcome>
      <sec_outcome>Knowledge. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Knowledge Questionnaire.</sec_outcome>
      <sec_outcome>Attitude. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Attitude questionnaire.</sec_outcome>
      <sec_outcome>Self- Steem. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Rosenberg Self-Esteem Scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>center for community based participatory research, Tehran university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-11</approval_date>
        <contact_name>center for community based participatory research, Tehran university of medical sciences</contact_name>
        <contact_address>Unit 9, floor 7, Gol complex, by Keshavarz Blvd.., Northern Kargar Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
